The following data is part of a premarket notification filed by Analogic Corp. with the FDA for C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional Printer For Ci, Model M3925a.
| Device ID | K041376 |
| 510k Number | K041376 |
| Device Name: | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Donald J Sherratt |
| Correspondent | Donald J Sherratt ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-24 |
| Decision Date | 2004-07-20 |
| Summary: | summary |